Aliskiren hemifumarate; valsartan - Generic Drug Details

What are the generic drug sources for aliskiren hemifumarate; valsartan and what is the scope of patent protection?

Aliskiren hemifumarate; valsartan is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; valsartan has ninety-three patent family members in thirty-one countries.

Summary for aliskiren hemifumarate; valsartan

International Patents:	93
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	aliskiren hemifumarate; valsartan at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for aliskiren hemifumarate; valsartan

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for aliskiren hemifumarate; valsartan

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

C09XA	Renin-inhibitors
C09X	OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

US Patents and Regulatory Information for aliskiren hemifumarate; valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009		DISCN	No	No			Y
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009		DISCN	No	No			Y

Expired US Patents for aliskiren hemifumarate; valsartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-001	Sep 16, 2009
Novartis	VALTURNA	aliskiren hemifumarate; valsartan	TABLET;ORAL	022217-002	Sep 16, 2009

International Patents for aliskiren hemifumarate; valsartan

Country	Patent Number	Title	Estimated Expiration
Israel	212075	תכשירים רפואיים המכילים שילוב של מעכב רנין ולפחות גורם רפואי אחד ושימושם בהכנת תרופות למניעת מחלה עיכוב התקדמותה או טיפול בה (Pharmaceutical compositions comprising a combination of a renin inhibitor and at least one therapeutic agent and uses thereof for the manufacture of medicaments for the prevention of, delay of progression of, or treatment of a disease)
Japan	6373931
Denmark	1341533

Supplementary Protection Certificates for aliskiren hemifumarate; valsartan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	300625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
0678503	C00678503/04	Switzerland		PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
1507558	113 5008-2012	Slovakia		PRODUCT NAME: ALISKIREN / AMLODIPIN / HYDROCHLORTIAZID; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - EU/1/11/730/060 20111122; FIRST REGISTRATION: CH 61678 01 - 61678 05 20110705

Market Dynamics and Financial Trajectory for Aliskiren Hemifumarate and Valsartan

Introduction to Aliskiren and Valsartan

Aliskiren hemifumarate and valsartan are two antihypertensive drugs that have been combined in a single formulation known as Valturna. Aliskiren is a direct renin inhibitor, while valsartan is an angiotensin II receptor blocker (ARB). Both drugs are approved for the treatment of hypertension in adults.

Market Overview

Global Aliskiren Market

The global aliskiren market has been growing at a moderate pace, driven by several key factors. The increasing effectiveness of aliskiren in controlling hypertension, its ability to be combined with all classes of current antihypertensive drugs, and an increase in government initiatives and health awareness are significant drivers[3].

Market Segmentation

The aliskiren market is segmented based on type, application, and geography. The types include 150 mg and 300 mg tablets, with the 300 mg tablet being a more commonly prescribed dose. Applications include hospitals, drug stores, and other healthcare settings. Geographically, the market is divided into North America, Europe, Asia Pacific, and the rest of the world, with North America expected to grow at the highest CAGR during the forecast period[3].

Financial Trajectory

Revenue Growth

The aliskiren market is projected to grow significantly from 2021 to 2028, driven by its increasing adoption and the expanding patient base requiring antihypertensive treatments. The combination of aliskiren with other antihypertensive drugs, such as valsartan, enhances its market appeal and revenue potential[3].

Key Players

Major players in the aliskiren market include Novartis, Noden Pharma, LGM Pharma, Cayman, Vitae-GSK, Daiichi Sankyo, Merck-Frost, Mitsubishi-Tanabe, Takeda, and Cadila Healthcare. These companies play a crucial role in the production, distribution, and marketing of aliskiren and its combination products like Valturna[3].

Clinical Efficacy and Market Impact

Efficacy of Aliskiren and Valsartan Combination

Studies have shown that the combination of aliskiren and valsartan (Valturna) is more effective in lowering blood pressure compared to monotherapy with either drug. For example, a randomized, double-blind study involving 451 patients with stage 2 hypertension found that the aliskiren/valsartan combination lowered systolic blood pressure more significantly than valsartan alone[4].

Probability of Achieving Blood Pressure Goals

The combination of aliskiren and valsartan increases the likelihood of achieving target blood pressure levels. According to clinical studies, patients treated with Valturna 300/320 mg had a higher probability of achieving systolic and diastolic blood pressure control compared to those treated with aliskiren or valsartan alone[2].

Safety and Regulatory Considerations

Contraindications and Warnings

The use of aliskiren with ARBs or ACEIs in patients with diabetes is contraindicated due to the risk of renal impairment, hypotension, and hyperkalemia. This was highlighted in the ALTITUDE trial, which was terminated early due to these adverse effects[5].

FDA Actions

Following the ALTITUDE trial, the FDA issued new warnings and contraindications for aliskiren-containing products, including Valturna. Valturna was no longer marketed after July 2012 due to these safety concerns[5].

Market Challenges

High Cost and Production Constraints

Despite its efficacy, the aliskiren market faces challenges such as the high cost of the drug components and production constraints. These factors limit the market growth and accessibility of the drug to a broader patient population[3].

Poor Bioavailability

Aliskiren has poor bioavailability, which is further reduced when taken with a high-fat meal. This can impact its effectiveness and patient compliance, although the combination with valsartan may help mitigate some of these issues[1].

Competitive Landscape

The competitive landscape of the aliskiren market is characterized by the presence of several major pharmaceutical companies. Novartis, the innovator of both aliskiren and valsartan, plays a significant role in the market. Other key players are also investing in research and development to enhance the efficacy and safety of aliskiren-based treatments[3].

Future Outlook

Increasing Demand for Personalized Medicines

The demand for personalized medicines and better diagnostic facilities is expected to propel the global aliskiren market. As healthcare systems become more sophisticated, the need for targeted antihypertensive therapies like aliskiren and its combinations will likely increase[3].

Geographic Expansion

The aliskiren market is expected to grow significantly in regions like North America and Europe, driven by the presence of major players and increasing health awareness. Asia Pacific is also a promising market due to its large population and growing healthcare sector[3].

Key Takeaways

• Efficacy: The combination of aliskiren and valsartan is more effective in lowering blood pressure than monotherapy.
• Safety Concerns: Concomitant use with ARBs or ACEIs in diabetic patients is contraindicated due to renal impairment, hypotension, and hyperkalemia risks.
• Market Growth: The global aliskiren market is growing, driven by increasing effectiveness, government initiatives, and health awareness.
• Challenges: High cost, production constraints, and poor bioavailability are significant challenges.
• Future Outlook: Increasing demand for personalized medicines and geographic expansion are expected to drive market growth.

FAQs

What is the primary use of aliskiren and valsartan?

Aliskiren and valsartan are used in combination (Valturna) to treat hypertension in adults.

Why was Valturna no longer marketed after July 2012?

Valturna was no longer marketed after July 2012 due to safety concerns highlighted in the ALTITUDE trial, including risks of renal impairment, hypotension, and hyperkalemia in diabetic patients.

How effective is the combination of aliskiren and valsartan in lowering blood pressure?

The combination of aliskiren and valsartan is more effective in lowering blood pressure compared to monotherapy with either drug, with significant reductions in both systolic and diastolic blood pressure.

What are the major challenges facing the aliskiren market?

The major challenges include high cost, production constraints, and poor bioavailability of aliskiren.

Which regions are expected to drive the growth of the aliskiren market?

North America and Europe are expected to drive the growth, with Asia Pacific also being a promising market due to its large population and growing healthcare sector.

Sources

1. Clinical Pharmacology and Biopharmaceutics Review: "Aliskiren/Valsartan Formulation: Bilayer film-coated oral tablet" - FDA.
2. RxList: "Valturna (Aliskiren and Valsartan, USP Tablets)".
3. Verified Market Research: "Aliskiren Market Size, Share, Scope, Trends, Opportunities & Forecast".
4. PubMed: "Comparison of the effects of aliskiren/valsartan in combination versus valsartan alone in stage 2 hypertension".
5. FDA: "New Warning and Contraindication for blood pressure medicines containing aliskiren".

Last updated: 2024-12-17